Overdosing on Authority: Negative Side Effects of the FDA's Proposal for Generic Label Changes May Include Increased Costs and Liabilities
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Overdosing on Authority: Negative Side Effects of the FDA's
Proposal for Generic Label Changes May Include Increased
Costs and Liabilities
The risk reasonably to be perceived defines the duty to be obeyed, and risk
imports relation; it is risk to another or to others within the range of
apprehension. ,
I. INTRODUCTION
A generic drug is both pharmaceutically equivalent and bioequivalent to its
brand-name counterpart.2 A variance can, however, exist between the inactive
ingredients of the respective drugs.3 Although the two drugs are not required to
be identical, their warning labels must be exactly the same.4 It is the brand-
name manufacturer's responsibility to ensure that the warning labels are both
accurate and adequate, and the generic manufacturer's corresponding duty to
maintain an identical drug label.5 This duty of sameness prohibits generic
drug manufacturers from making unilateral changes to their warning labels.6
Despite generic manufacturers' forced reliance on brand-name warning
labels, brand-name manufacturers are immune from liability for failure-to-warn
or negligence claims arising from generic drugs.7 In a majority of
jurisdictions-as long as the drug that caused the injury was generic-brand-
name manufacturers escaped negative judgments, even though they played an
1. Palsgrafv. Long Island R.R., 162 N.E. 99, 100 (N.Y. 1928).
2. See 21 U.S.C. § 355(j)(2)(A)(iii)-(iv) (2012) (describing requirements for generic manufacturers'
abbreviated approval of new drug applications); see also Facts About Generic Drugs, U.S. FOOD AND DRUG
ADMIN., http://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/understandinggener
icdrugs/ucm167991.htm (last updated Sept. 9, 2012) [http://perma.cc/7T9P-5FKB] (explaining generic drugs
must meet same specifications and quality standards as brand-name drugs).
3. See 21 C.F.R. § 320.1(c) (2009) (defining pharmaceutical equivalence as drug with identical dosage
and identical amount of same active ingredient).
4. See In re Darvocet, 756 F.3d 917, 923 (6th Cir. 2014) (outlining generic manufacturers' postmarket
duty of sameness).
5. See, e.g., 21 U.S.C. § 355(j)(2)(A)(v) (2012) (indicating application for generic drug must contain
same label approved for brand-name drug); § 355(j)(4)(G) (explaining acceptance of generic drug application
unless insufficient similarity to brand-name drug label); 21 C.F.R. § 314.127(a)(7) (2015) (stating FDA's
refusal of generic drug application stems from labels differing from brand-name labels).
6. See Dolin v. SmithKline Beecham Corp., 62 F. Supp. 3d 705, 711 (N.D. Ill. 2014) (noting Hatch-
Waxman Act prohibits generic manufacturers changing warning labels independent of brand-name
manufacturers).
7. See Fisher v. Pelstring, No. 4:09-cv-00252-TLW, 2010 WL 2998474, at *8 (D.S.C. July 28, 2010)
(dismissing brand-name manufacturers from negligence suit because they owed no duty to plaintiffs).](ViewImageLocal?handle=hein.journals/sufflr49&div=12&collection=&method=preview&ext=.png&size=3)
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